ACTIVE_NOT_RECRUITING

Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors

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Conditions

Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-9911 when given alone or in combination with an anti-programmed cell death protein 1 (PD-1) monoclonal antibody in participants with advanced solid tumors. The primary objectives of this study are to: * Assess the safety and tolerability of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors * Identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended dose for expansion (RDE) of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors

Official Title

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-9911 as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors

Quick Facts

Study Start:2023-10-09
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06082960

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Parts A, C, and D:
  2. * Participants with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or are ineligible for all treatments known to confer clinical benefit
  3. * Part B:
  4. * Participants whose cancer previously derived clinical benefit from immune checkpoint inhibitors, or who have advanced solid tumor types for which immune checkpoint inhibitors are considered the standard of care and who have received, been intolerant to, or are ineligible for all treatments known to confer clinical benefit
  5. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. * Evaluable (Part A) or measurable (Parts B, C, and D) disease as per Response Criteria Evaluation in Solid Tumors (RECIST) v1.1 criteria
  7. * Adequate organ functions
  8. * Tissue requirement:
  9. * Parts A-D: must be willing to provide baseline tumor tissue prior to enrollment
  10. * Part A backfill cohorts: a biopsy should be obtained prior to treatment and on treatment, if safely feasible
  11. * Participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception
  1. * Positive serum pregnancy test or lactating female
  2. * History of intolerance, hypersensitivity, or treatment discontinuation due to life- threatening immune-related adverse events on prior immunotherapy
  3. * Receipt of the therapies listed below within the specified timeframe prior to planned Cycle 1 Day 1 including: major surgery (\< 4 weeks), immunotherapy or biologic therapy (\< 28 days), chemotherapy (\< 21 days), targeted small molecule therapy (\<14 days or 5 half-lives, whichever is sooner), hormonal or other adjunctive therapy (\< 14 days), radiation therapy (\< 21 days), live vaccine (\< 28 days)
  4. * Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation
  5. * Diagnosis of immunodeficiency, or requires systemic corticosteroids (\> 10 mg of prednisone daily, or equivalent)
  6. * History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years prior to the start of study drug
  7. * History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, drug-induced pneumonitis, or severe radiation pneumonitis (excluding localized radiation pneumonitis)
  8. * Active second malignancy. Note: individuals with a history of malignancy that have been completed treated, with no evidence of active cancer for 2 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence are allowed to enroll.
  9. * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  10. * Symptomatic cardiovascular disease
  11. * Active serious infection requiring ongoing treatment
  12. * Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV.
  13. * Symptomatic ascites or pleural effusion

Contacts and Locations

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, 06520
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
NEXT Oncology
San Antonio, Texas, 78229
United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Gilead Sciences

  • Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-09
Study Completion Date2026-11

Study Record Updates

Study Start Date2023-10-09
Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumors